The present invention relates to a device for repairing a dilated heart ventricle by reshaping it mechanically.
Heart failure (HF), often called congestive heart failure (CHF) or congestive cardiac failure (CCF), occurs when the heart is unable to provide sufficient pump action to distribute blood flow to meet the needs of the body. Heart failure can cause a number of symptoms including shortness of breath, leg swelling, exercise intolerance, and even death.
Common causes of heart failure include myocardial infarction and other forms of ischemic heart disease, hypertension, valvular heart disease, and cardiomyopathy.
Cardiomyopathy (literally “heart muscle disease”) is the measurable deterioration of the function of the myocardium (the heart muscle) for any reason, usually leading to heart failure. Common symptoms are dyspnea (breathlessness) and peripheral edema (swelling of the legs). People with cardiomyopathy are often at risk of dangerous forms of irregular heart beat and sudden cardiac death. The most common form of cardiomyopathy is dilated cardiomyopathy.
Dilated cardiomyopathy (DCM) is a condition in which the heart becomes weakened and enlarged and cannot pump blood efficiently. In DCM a portion of the myocardium is dilated, often without any obvious cause. Left or right ventricular systolic pump function of the heart is impaired, leading to progressive cardiac enlargement and hypertrophy, a process called remodeling.
Dilated cardiomyopathy is the most common form of non-ischemic cardiomyopathy. It occurs more frequently in men than in women, and is most common between the ages of 20 and 60 years. About one in three cases of congestive heart failure (CHF) is due to dilated cardiomyopathy. Dilated cardiomyopathy also occurs in children.
Another common symptom of heart dilatation is the onset of Mitral valve insufficiency commonly called functional MR. Functional MR results from loss of coaptation of the valve leaflets characterized by dilatation of the mitral valve annulus or papillary muscle displacement with chordae tethering, and is as well considered as an ongoing impetus of progression for dilated cardiomyopathy.
To date, there is no surgical or other interventional treatment for the shape deterioration or remodeling of the heart. Current treatment methods depend on the type of cardiomyopathy and condition of the disease, and may include medication (a conservative treatment) or interventions intended for management of heart arrhythmias. Such treatment methods may include implanted pacemakers for slow heart rates, defibrillators for those prone to fatal heart rhythms, or ablations for recurring arrhythmias that cannot be eliminated by medication or pacemakers. The goal of treatment is often symptom relief, but not the actual cure of the disease. In severe heart failure cases patients may require ventricular assist devices and eventually a heart transplant.
Not many attempts were made to develop surgical or interventional devices for mechanical re-shaping of the dilated heart. One of the most notable attempts was made by the Coapsys device which was designed to reverse the remodeling of the left ventricle and treat functional MR.
The Coapsys device consisted of posterior and anterior extracardiac pads implanted surgically and connected by a flexible, transventricular subvalvular cord. By shortening that cord after the pads were in place, the ventricular walls were drawn together and the mitral annulus and subvalvular apparatus were compressed. The re-shaping of the Mitral annulus improved coaptation of the valve leaflets and reduced the MR grade. The device also decreased direct left ventricular wall stress and induced positive ventricular remodeling. Unfortunately, the implantation of the Coapsys device is implemented through a median sternotomy on a beating heart.